Skyhawk Therapeutics Inc., one of the early leaders in developing small-molecule drugs that target RNA, closed out the year with yet another big pharma partnering deal, an alliance with Vertex Pharmaceuticals Inc., in which it is getting $40 million up front plus up to $2.2 billion more in milestones and royalties on product sales. Read More
The challenging mucositis space chalked up another failure in dusquetide, the innate defense regulator from Soligenix Inc., which fell short in a pivotal, phase III study that enrolled 268 patients to test the small-molecule peptide. “We sort of thought so,” Dawson James analyst Jason Kolbert in a Dec. 22 report, with a neutral rating and no price target. Read More
The BioWorld Drug Developers index is currently tracking up more than 9% in value so far this month and is on target, with a handful of trading days left before the end of the year, to close up over 35% for 2020, well ahead of the general markets. Read More
NEW DELHI – India is taking a multipronged approach to developing and distributing vaccines against COVID-19, with at least 10 different products under development, domestically or through collaborations with foreign developers. Vaccinations are likely to begin early next year but, with a population of around 1.2 billion, it is unlikely India will be able to vaccinate everybody it needs to before the end of 2022. Read More
After nearly three months of the U.S. federal government operating on stopgap spending measures, Congress has agreed to a $1.4 trillion spending bill for fiscal 2021. The omnibus package, which includes $97 billion for the Department of Health and Human Services, gives both the FDA and NIH small increases in funding. Read More
The U.S. FDA has granted emergency use authorization (EUA) for thousands of products for the COVID-19 pandemic, and the agency is legally required to advise companies of their post-pandemic options for new marketing authorization. Conversely, companies that fail to deal with inventory for expired EUAs may find themselves in the crosshairs of the FDA, whistleblowers, and federal and state attorneys, suggesting that manufacturers of devices should have a plan for dealing with unused inventories once the public health emergency comes to an end. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: USPTO to expand diversity in innovation; Opioid prescriptions could cost Walmart billions. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Appili, Biogen, Cytodyn, Dr. Reddy’s, Innovation, Kempharm, Nicox, Ocular, Onconova, Orchard, Polyphor, Takeda, Uniqure, Vertex, Ziopharm. Read More
